Schering to Pay $435 Million

Schering-Plough Corp. agreed to pay $435 million in connection with a federal investigation into Schering's marketing of drugs for unapproved uses and overcharging Medicaid for various drugs, according to an article in today's L.A. Times.  Federal investigators found evidence Schering marketed drugs for off-label uses not approved by the FDA.  For example, Schering pleaded guilty to making false statements in connection with Temodar, which generated $588 million in sales last year.  According to U.S. Attorney Michael Sullivan, Temodar had been FDA-approved only for treatment of anaplastic astrocytoma, a brain tumor, in patients who had not responded well to other treatments, but Schering marketed the drug for other brain cancers, even though such treatments were not FDA-approved.  Based on their own expertise, doctors may independently prescribe medications for off-label purposes.